Forcing covid19 vaccines ignores scientific information

In the case of COVID-19 vaccines, the censorship aims to stamp out any questions about a universal vaccination program that, it is now clear, was based on the false premise that low-risk individuals must get vaccinated to halt the spread of COVID-19 and end the pandemic. Almost a year into the global vaccination campaign – and starting long before omicron arrived – all the data stand in stark opposition to this belief.

 

Rapidly waning vaccine efficacy and COVID-19 surges in countries and regions with high vaccination rates – including Israel, the United Kingdom, Singapore, and now Europe, as well as high-vaccination U.S. states like Vermont – are evidence that vaccinated individuals can spread COVID-19 at rates comparable to the unvaccinated. Multiple studies have shown that viral load in vaccinated individuals with COVID-19 is the same as in the unvaccinated.

 

Most damning, reports regularly published by the British government show that for every age group from 30 years and up, vaccinated individuals are now actually more likely to test positive for COVID-19. In the case of the 40-59-year-old age group, in the latest report the rate is twice as high among the vaccinated.

https://thefederalist.com/2021/12/14/forcing-people-into-covid-vaccines-ignores-important-scientific-information/

A cost-benefit analysis of Covid19 vaccine mandates

Dr Martin Lally

Capital Financial Consultants Ltd

30 November 2021

Abstract

Covid-19 vaccine mandates for the general population must trade off the rights of those who object to being vaccinated against the costs that the unvaccinated impose upon the vaccinated, most particularly the increased risk to vaccinated people of death by covid-19.  This paper provides a methodology for doing so.  It is then applied to the case of New Zealand.  It reveals that even if the adverse impact of penalties on vaccine objectors (many of whom may have rational grounds for objecting) were as small as a reduction in their quality of life of 1% per year for a period of five years and the existence of unvaccinated people were entirely responsible for covid-19 infections amongst the vaccinated, the number of additional deaths amongst the vaccinated resulting from not adopting a vaccine mandate would be too few to justify a policy of mandating.  However, unlike the general population, health workers come into frequent and close contact with large numbers of sick people, who are prime targets for covid-19, and therefore the vaccine mandate may be justified for these workers.  This rationale does not apply to education workers, who are even less likely than the general population to come into frequent and close contact with people at high risk from covid-19.

The helpful comments of Michael Reddell, John Haywood, Lyndon Moore, Damon Collin, Richard Frogley, Jack Robles, Robert Kirkby, Rodney Hide, Grant Schofield, and Ian Harrison are gratefully acknowledged.  Agreement with the paper is not implied.

Introduction

Vaccine mandates for the general population are proving to be extremely controversial.  Opponents point to the right to choose whether to be vaccinated, and to concerns over the safety of the vaccine.  Proponents point to the costs that the unvaccinated impose upon the vaccinated, in particular the increased risk of covid-19 to vaccinated people (because the vaccine is imperfect) and the increased load on the public health system from unvaccinated people seeking treatment for covid-19 leading to some (vaccinated) people receiving an inferior level of care for non-covid conditions than they otherwise would and thereby dying earlier than they otherwise would.[1]  An important benchmark in assessing mandates involves actions that are clearly beneficial both privately and socially, and free of adverse private or social consequences, such as the use of car seat belts.  Accordingly, the first requirement here is to assess whether vaccine mandates are of this kind.  If so, they would be justified.  If not, then this would be another example of the trade-offs we face in life, individually or socially, and is therefore capable of being illuminated (and possibly resolved) by cost-benefit analysis.  This paper seeks to do so for New Zealand, which has imposed significant penalties on those failing to vaccinate.

The Rationality of Vaccine Opposition

Consider the case of a 80+ year old person.  For this group, Verity et al (2020, Table 1) gives an Infection Fatality Rate (IFR) for covid-19 of 7.8%, i.e., a probability of death if infected of 7.8%.  Application of this Verity et al (2020, Table 1) data to New Zealand’s population proportions by age group yields an overall population-wide IFR of 0.95% (Steyn et al, 2021, page 14).  By contrast, recent literature surveys suggest population-wide IFRs of 0.3 – 0.4% for Europe and the Americas (Ioannidis, 2021, page 10), and 0.70% for Europe and 0.58% for the Americas (Meyerowitz-Katz and Merone, 2021, Figure 2).  The midpoint is about 0.5%, which is approximately double the figure of 0.95% implied by the Verity et al (2020) data.  So, I halve Verity et al’s figure of 7.8% to yield an IFR of 3.9% for an 80+ year old.  Death rates from covid-19 also depend upon the health status of the individual, with the risk of death (if infected) being higher for those with various pre-existing conditions.  Bayes Theorem states that the probability of event A occurring conditional upon B occurring is the probability of B occurring conditional upon A occurring multiplied by the unconditional probability of A divided by the unconditional probability of B (Mood et al, 1974, page 36), i.e.,

In this case, A means death from covid-19 and B means suffering from a relevant pre-existing condition.  So, P(A) = 0.039.  Most covid-19 deaths involve people suffering from serious pre-existing conditions.  For example, in respect of those dying in New York City up to 13 May 2020, in those cases where the existing medical condition of the patient was known (no underlying condition or at least one underlying condition), 98% had at least one underlying condition (the set of conditions includes diabetes, cancer, heart disease, lung disease, and hypertension).[2]  Furthermore, this probability is similar across age groups.  This means P = 0.98.  In respect of P(B), this is the probability of an 80+ year old having any of the relevant pre-existing conditions.  Such conditions are common amongst 80+ year olds and I therefore assume P(B) = 0.50.  Substituting these parameters into equation (1) yields:

So, a randomly selected 80+ year old would have a probability of dying from covid-19 if infected of 3.9%, rising to 7.6% if they suffered from any of the relevant pre-existing conditions, i.e., 1/13.  This is without vaccination.  The vaccines reduce the risk of death by 85% to 88% on average over the first six months but rapidly wane beyond that point (Nordstrom et al, 2021, Table 2 and Table 5).  So, if vaccinated with boosters, the probability of death falls from 7.6% to 7.6%*0.15 = 1.14%, i.e., 1/88.  So, vaccination reduces the risk from 1/13 to 1/88.  The absolute reduction in risk is very large.

I now consider the case of a 10-19 year old who is not suffering from any of the relevant pre-existing conditions.  So, A still means death whilst B now means not suffering from any such conditions.  For a 10-19 year old, Verity et al (2020, Table 1) gives P(A) = 0.007%, which is halved to 0.0035% as above.  Also, P = 1 – 0.98 = 0.02.  In respect of P(B), this is the probability of a 10-19 year old not suffering from any of the relevant pre-existing conditions.  Such conditions are rare in 10-19 year olds and I therefore adopt a probability of them all being absent of 0.95.  Substituting these parameters into equation (1) yields:

So, a randomly selected 10-19 year old would have a probability of dying from covid-19 if infected of 0.0035%, falling to 0.00007% if they did not suffer from any of the relevant pre-existing conditions, i.e., 1/4.3 million.  This is without vaccination.  The vaccines reduce the risk of death by 85% to 88% on average over the first six months but rapidly wane beyond that point (Nordstrom et al, 2021, Table 2 and Table 5).  So, if vaccinated with boosters, the probability of death falls from 1/4.3 million to 1/28 million.  The absolute reduction in risk is very small.

Table 1 shows these results and others, for the unvaccinated.  In moving from the first to the last age group, the probability of all relevant pre-existing conditions being absent is assumed to decline linearly from 95% for the first group to 50% for the last group.

 

Table 1: Risk of Death from Covid-19 if Infected and Unvaccinated

_______________________________________________________

Healthy                                            Not Healthy

_______________________________________________________

10-19              1/4,300,000                                      1/1,500

20-29              1/290,000                                         1/750

30-39              1/100,000                                         1/440

40-49              1/48,000                                          1/300

50-59               1/11,000                                         1/100

60-69                1/3,300                                          1/40

70-79                 1/1,300                                         1/20

80+                      1/625                                        1/13

_______________________________________________________

All vaccines have some side-effects, which could include death.  A rational person will weigh these risks against the personal benefits of the vaccine (reduced risk of their death from covid-19).  The blinded, randomised, placebo-controlled studies submitted in support of the vaccine being approved were very favourable to the vaccine, but the sample sizes were too small to detect adverse side effects at the very low rates that would still make them worse than the risk of death by covid-19 in young healthy people.  For example, Pollack et al (2020) reports on a study by Pfizer, involving 44,000 participants of which half were given the vaccine and half a placebo.  Covid-19 was diagnosed in considerably more cases in the placebo group than the vaccinated group (162 to 8), but the only subsequent deaths in either group (six participants) were judged to be unrelated to covid-19, the vaccine, or the placebo.  However, suppose the risk of death from the vaccine were 1/50,000 and independent of age or health.  This risk is entirely consistent with the absence of any such deaths amongst the 22,000 participants given the vaccine, but Table 1 reveals that such a risk would exceed the risk from covid-19 amongst healthy people under the age of 45.[3]  So, Pollack et al (2020) does not provide any confidence that the risk of death from the vaccine is less than that from covid-19 for healthy people under the age of 45.

Pollack et al (2020) also reports four cases with serious side effects, all of them in the vaccinated group. This is a rate of 1/5,000.  Standard cost-benefit analysis for health issues involves discounts to Quality Adjusted Life Years (QALYs) for imperfect health status.  Beaudet et al (2014, Table 3) estimates quality of life discounts for various medical events, none of which appear in Pollack’s set.  Using an average discount of 10% over the conditions reported by Pollack, the 1/5,000 risk of such conditions arising from the vaccine is equivalent to a risk of death of 1/50,000.  Table 1 then implies that (leaving aside the risk of death) it would then be rational for any healthy person under the age of about 45 to decline the vaccine if these risks of serious side effects were not age or health related.[4]  Coupling this risk of serious side effects with whatever the risk of death is, the threshold age below which vaccination is not optimal would be even higher than the figure of 45 estimated in this paragraph.

An alternative source of information on the side effects of the vaccine is the reports by government entities on all vaccinated people.  These reports involve much larger numbers of participants but lack the statistical controls of blinded, randomised, placebo-controlled studies.  Medsafe (2021a) reports 97 deaths following the vaccine of which one was likely due to the vaccine, six were still under investigation, 43 were unlikely to be due to the vaccine, and 47 could not be assessed due to insufficient information.[5]  In recognition of the uncertainty here, Medsafe (2021b) also compares actual deaths amongst the vaccinated within 21 days of a dose with the expected number of deaths, with the latter based upon data from 2009-2018 (the “natural death rate”), and finds that actual deaths are lower (600 versus 1,100).  Prima facie, this suggests that the vaccine is not causing deaths.  However, the fact that the actual deaths are below rather than equal to the expected deaths (and markedly below) reveals that the prediction model is poor or things other than the vaccine are significantly affecting the death rate, and therefore the vaccine could be inducing a moderate number of deaths that are masked by these other phenomena.  For example, suppose the vaccine had induced 34 deaths amongst the 3.4 million people vaccinated to date in New Zealand, which is not inconsistent with Medsafe’s disclosures.  This implies a risk of death of 1/100,000, and Table 1 implies that it would be rational for any healthy person under the age of 35 to decline the vaccine if the risk from the vaccine were not age or health related.  However, 34 deaths is far too small a number to be detected by the actual to expected comparison undertaken by Medsafe (2021b).  So, Medsafe’s disclosures on risks of death provide no confidence that the risk of death from the vaccine is less than from covid-19 for healthy people under the age of 35.

Medsafe (2021a) also reports 1,200 “serious adverse events” following vaccination that are suspected to be due to the vaccine, up till 30 October 2021, none of which involved death.  These include strokes, heart attacks and facial paralysis.  Across the 3.4 million people vaccinated up until this point (half the number of doses administered), this is 1/2,800.  Standard cost-benefit analysis for health issues involves discounts to Quality Adjusted Life Years (QALYs) for imperfect health status.  Beaudet et al (2014, Table 3) estimates quality of life discounts for various medical events, of which heart attack and strokes appear in the Medsafe list, with discounts of 11% and 16% respectively.  Using an average discount of 10% over the conditions reported by Medsafe, the 1/2,800 risk of such conditions arising from the vaccine is equivalent to a risk of death of 1/28,000 (which is equivalent to 120 deaths amongst the 3.4 million people vaccinated).  Table 1 then implies that it would then be rational for any healthy person under the age of about 50 to decline the vaccine if these risks of serious side effects were not age or health related.[6]  This represents the majority of New Zealand’s population.

Coupling this risk of serious side effects with whatever the risk of death is, the threshold age below which vaccination is not optimal would be even higher than the figure of 50 estimated in the previous paragraph.  I do not imagine that most or perhaps even any of the vaccine objectors have performed this kind of analysis on the vaccine risks.  Instead, I expect that they would instead simply have a sense that they were not at any material risk of death by covid-19 but felt that the risks from the vaccine were likely to be higher.  The analysis and examples here are consistent with such thinking.

This analysis presumes that vaccine objectors trust official sources of information.  Medsafe’s (2021a) report is based upon reporting by patients and health workers, and the serious adverse events are presumably reported by doctors.  Medsafe (2021a) asserts that “The protective benefits of vaccination against COVID-19 far outweigh the potential risks of vaccination.” However, Medsafe does not perform or cite any analysis in support of this conclusion, and the analysis above suggests that the assertion is false for most New Zealanders.  Medsafe’s assertion then looks like cheerleading rather than impartial reporting of adverse events.  A related problem occurred with the elimination strategy pursued by the government, in that its external advisers continued to publicly support this strategy even after the only cost-benefit analysis carried out by any of them on elimination versus mitigation revealed that mitigation was preferable (Lally, 2021a).  All of this could reasonable lead some people to doubt official sources of information.

This analysis also presumes that vaccine objectors ignore the benefit to their fellow citizens from them being vaccinated, i.e., the reduction in the risk of highly susceptible vaccinated people becoming infected as a result of the existence of unvaccinated people, and subsequently dying.  However, rationality does not require selflessness.  In addition, vaccine objectors could reasonably believe that all vaccinated people will eventually become infected through transmission amongst vaccinated people and therefore there would be no social benefit from them (the objectors) being vaccinated.

In conclusion, the risks of death from covid-19 if infected are so low for healthy adults under the age of 50 (less than 1/30,000) that such people could rationally prefer not to be vaccinated purely on the basis of the number of serious (but non-fatal) side-effects from the vaccine that have been reported to date by Medsafe.  Additionally allowing for even a low possibility of death from the vaccine strengthens the case amongst such people for not being vaccinated, and further allowing for even moderate scepticism about official sources of information further strengthens the case. 

 Cost-Benefit Analysis

Having established that many people might rationally object to the vaccine, I now undertake a cost-benefit analysis on the mandating of it.  Let N denote the number of people in a country who object to being vaccinated against covid-19.  Standard cost-benefit analysis for health issues involves discounts to Quality Adjusted Life Years (QALYs) for imperfect health status.  For example, a person suffering from type 2 diabetes without complications warrants a discount of about 20% per year of their remaining life (Beaudet et al, 2014, Table 3).  The same principle applies to a vaccine mandate, i.e., it reduces the quality of life of those objecting to being vaccinated.  For some of these people, the effects of the penalties for non-vaccination may extend to all of their remaining lives.  This might occur because the objector has given up a preferred job rather than being vaccinated.  Alternatively, having acceded to being vaccinated because of the penalties, the objector is then subject to what they believe to be the risk of vaccine side-effects that exceeds the reduction in their risk of dying from covid-19, and they may also suffer from anxiety over these future risks, and from anxiety over the possibility that the vaccine has caused a health condition that they experienced at some point after being vaccinated.[7]  The mandating of vaccine boosters would aggravate these effects for objectors who were induced into being vaccinated.  For other objectors, the effects of the penalties would fade quickly.  In recognition of the latter group, I (conservatively) adopt a horizon of five years for the quality of life effects of penalties on all objectors.  Let W denote the average annual discount on the quality of life of objectors arising from the penalties.  The QALYs lost from a mandating policy is then N*5*W.

Now consider the costs that the unvaccinated impose on the rest, of the types mentioned above.  Let D be the expected additional deaths amongst vaccinated people from the existence of unvaccinated people, if mandating is not adopted compared to being adopted, and with minimal other measures to contain the virus.  The deaths here are of people likely to have low residual life expectancies and health problems that would lower their quality of life had they not died from covid-19.  Lally (2021b, section 2.2) estimates the average residual life expectancy of the covid-19 victims (had they not died from covid-19) as five years for European countries and the discount for health problems during this five-year period at 20% per year.  The QALYs lost amongst vaccinated people from failure to adopt a mandating policy is then D*5*0.8, i.e., D*4.  There will also be QALY losses amongst vaccinated people who survive the infection but suffer significant symptoms for a protracted period (long covid), but Lally (2021b, pp. 17-18) finds that this contributes very little to the QALY losses from deaths.

In summary, if vaccine mandating is adopted, the N people alive today who object to being vaccinated will experience a QALY loss of N*5*W whilst the vaccinated avoid a QALY loss of D*4.  So, mandating is warranted only if D*4 exceeds N*5*W.

Application to New Zealand

I now apply this cost-benefit model to New Zealand.  Penalties for failure to vaccinate in the form of loss of employment have already been introduced for some categories of workers, including those in health and education, and there are plans to apply lesser penalties to the general population over the age of 12.[8]  Approximately 84% of the New Zealand population (of 5 million) is in the 12+ group.[9]  This constitutes 4.2 million people.  As of 15 November 2021, 10% of this group had not yet had a first dose (420,000) and yet had ample opportunity to do so by that time.  These people can therefore reasonably be viewed as vaccine objectors.  In addition, some of those vaccinated up until this date are likely to have done so because of or in anticipation of penalties.  So, the set of New Zealanders who object to being vaccinated (N) is at least 420,000.

In respect of the average annual discount on the quality of life of people subject to penalties for not being vaccinated (W), this average will reflect considerable variation across objectors.  Taking account of the fact that a person suffering from type 2 diabetes warrants a discount of about 20% per year of their remaining life (Beaudet et al, 2014, Table 3), a value for W of at least 1% per year is plausible.

Conditional on W being 1% per year, mandating would then be warranted only if D*4 exceeds 420,000*5*0.01, i.e., D exceeds 5,200.  This means 5,200 additional deaths amongst vaccinated people (from covid-19 or from other conditions arising from unvaccinated people overloading the public health system with covid-19 symptoms), if mandating is not adopted compared to it being adopted.  In respect of the public health system being overloaded by unvaccinated people with covid-19 symptoms, any society willing to impose significant penalties upon the unvaccinated would presumably be willing to apply a much lower level of health care to them should they experience covid-19 symptoms, which would significantly mitigate the health system overload.  Overload can also be further mitigated by expanding the capacity of the health system.[10]  This suggests that the principal adverse effect of the unvaccinated upon the vaccinated is the additional deaths amongst the vaccinated arising from being infected with covid-19 because of the existence of unvaccinated people (who are likely to increase the spread of the virus).  So, vaccine mandating would be warranted only if failure to do so leads to a pool of unvaccinated people who thereby induce at least 5,200 additional deaths from covid-19 amongst the vaccinated.

I now consider whether at least 5,200 additional such deaths amongst the vaccinated could occur.  The worst case scenario for the 90% of the over 12s who vaccinate without mandating (4.2m*0.9 = 3.8m) is that they all become infected as a result of the existence of the unvaccinated people who could be induced into vaccinating by penalties.  In the absence of an effective vaccine, the proportion dying is the Infection Fatality Rate (IFR).  Recent surveys suggest figures of 0.3 – 0.4% for Europe and the Americas (Ioannidis, 2021, page 10), and 0.70% for Europe and 0.58% for the Americas (Meyerowitz-Katz and Merone, 2021, Figure 2).  The midpoint is about 0.5%, which implies 3.8m*0.005 = 19,000 dead.  However, this IFR relates to the entire population rather than only those over 12, and the latter IFR would be higher because the IFR is monotonically increasing with age.  Correction for this raises the IFR for the over 12s to about 0.60%.[11]  This implies 3.8m*0.006 = 23,000.  The vaccine reduces the risk of death by 85% to 88% on average over the first six months but this rapidly wanes beyond that point (Nordstrom et al, 2021, Table 2 and Table 5).  If a booster is used at that point, the average reduction in the death rate would then be at least 85%.  This implies 23,000*(1 – 0.85) = 3,400 deaths amongst the vaccinated.

This is the worst case, and is unlikely to occur for three reasons.  Firstly, it is unlikely that all of the 3.8m vaccinated would be infected.  Secondly, amongst those infected, it is inconceivable that all would be infected as a result of the pool of unvaccinated people, i.e., some of the vaccinated would be infected even if there were no unvaccinated people because the vaccine does not eliminate the risk of its recipients transmitting the virus and therefore vaccinated people could be infected by other vaccinated people.[12]  In fact, all of the vaccinated might become infected even if the unvaccinated pool did not exist, through the virus transmitting through the vaccinated.  Thirdly, amongst those vaccinated who were infected as a result of the unvaccinated pool, some would be infected as a result of the vaccine objectors who will not accede to vaccination despite the penalties, and this group exists regardless of whether a mandating policy is adopted.  Taking account of all three of these points, the additional covid-19 deaths amongst the vaccinated in the absence of vaccine mandating would be significantly less than 3,400.

An even lower figure is implied by Steyn et al (2021b, Table 3), who estimate the deaths from covid-19 in New Zealand within one year at 3,539 if 90% vaccination of the 12+ group were achieved and minimal other measures to contain the virus were adopted (test, trace, isolate and quarantine).  This figure of 3,539 is based inter alia on the IFR data from Verity et al (2020).  As argued above, that data overestimates the IFR by 100%.  So, the appropriate figure is 1,800 deaths.  Of these 1,800 deaths, some would be amongst the 10% of adults who were unvaccinated (in their analysis) and these must be deducted because they are irrelevant to the current analysis.  Steyn et al (2021b, Table 1) adopts an estimate of 94% for the effectiveness of the vaccine against severe disease.  I assume the same effectiveness against death from covid-19, in their analysis.  So, with a 90% vaccination rate, for every 10 deaths amongst the unvaccinated, there would be 90 amongst the vaccinated if the vaccine were completely ineffective and 90*(1 – 0.94) = 5.4 taking account of the vaccine’s 94% effectiveness.  Consequently, of these 1,800 deaths, the proportion vaccinated would be 5.4/(10 + 5.4) = 0.35.  This implies 1,800*0.35 = 630 deaths amongst the vaccinated.  Not all of these deaths would be due to the unvaccinated pool, and even fewer due to the subset of the unvaccinated that would accede to being vaccinated in the face of the penalties. So, the number of deaths amongst the vaccinated due to the existence of the unvaccinated who would accede to being vaccinated in the face of the penalties is up to 630.

Thus, using the figure of up to 630 deaths amongst the vaccinated implied by Steyn et al (2021b) or even up to 3,400 deaths from the earlier analysis, failure to adopt a mandating policy will not lead to at least 5,200 additional deaths from covid-19 amongst the vaccinated.  This threshold figure of 5,200 presumes that the quality of life impact on the objectors is only 1% per year for five years.  If it were 2% per year, the threshold for covid-19 deaths amongst the vaccinated would double to 10,400.  If the unvaccinated pool had little effect on the rate of infection amongst the vaccinated (because of transmission amongst the vaccinated), the number of additional covid-19 deaths amongst the vaccinated arising from failure to adopt a mandating policy would be close to zero, which further undercuts the merits of a mandating policy.

The Case of Health Workers and Education Workers

The set of workers for whom failure to vaccinate leads to loss of their job includes health workers, of which there are currently about 213,000 in New Zealand (Ministry of Health, 2020, page 1).  The cost-benefit analysis for them differs from that of the general population because they come into frequent and close contact with large numbers of sick people, who are the prime targets of covid-19.  If the proportion of health workers who are vaccine resistant is the same as for the general adult population (10%), this would imply 21,000 people.  However, health workers are likely to have a very low proportion of objectors, because they are accustomed to being directed by their employers on patient safety related matters.  Suppose the proportion is instead 2%, which implies 4,000 people.  Since loss of their jobs would impose a substantial loss upon them, I presume that virtually all of them would comply with a mandate.

In the previous section, failure to mandate the vaccine would lead to up to 630 deaths amongst the vaccinated.  The QALY losses resulting from this (630*5*0.8 = 2,500) are less than the QALY losses from the 420,000 objectors being subject to penalties (420,000*5*0.01 = 21,000) and therefore mandating is rejected for the general population.  However, without mandating, suppose a small subset of these 420,000 unvaccinated adults (the 4,000 health workers referred to above) would be responsible for a disproportionate fraction of these 630 deaths because these 4,000 workers are collectively in frequent and close contact with most of the 630 susceptible people.  In particular, suppose in the absence of mandating that they would be responsible for half of these deaths (315 people).  In this case the QALY losses resulting from these deaths (315*5*0.8 = 1,260) would be more than the QALY losses from these 4,000 being subject to penalties (4,000*5*0.01 = 200) and therefore mandating would be warranted for these 4,000 people.  In fact, if these 4,000 health workers were responsible for half of the 630 deaths, their QALY losses per person per year for five years could be as large as 6.3% (rather than the figure of 1% used up until this point) before mandating was no longer optimal.

This analysis does not imply that vaccination should be mandated for health workers, because the 630 vaccinated people who might die might do so even if there were no unvaccinated people, i.e., they could all be infected through transmission of the virus amongst vaccinated people.  However, unlike the case for mandating vaccines for the adult population in general (which is not supported by a cost-benefit analysis), it is possible that mandating vaccination for health workers is supported by a cost-benefit analysis as shown in this section.

The set of workers for whom failure to vaccinate leads to loss of their job also includes education workers.  Unlike health workers, education workers do not come into frequent and close contact with large numbers of people who are the prime targets of covid-19.  So, the argument for mandating the vaccine for health workers does not apply to education workers. In fact, the argument for mandating the vaccine for education workers is even weaker than it is for the adult population in general, because the kinds of people that education workers encounter in their jobs (those under 25) are the least likely to succumb to covid-19.  Since there is no case for mandating the vaccine amongst the general adult population, there is no case for mandating it amongst education workers.

Conclusions

Vaccine mandates for the general population are proving to be extremely controversial.  Opponents point to the right to choose whether to be vaccinated, and to concerns over the safety of the vaccine.  Proponents point to the costs that the unvaccinated impose upon the vaccinated, most particularly the increased risk to vaccinated people of death by covid-19 (because the vaccine is imperfect).  This is yet another example of the trade-offs we face in life, individually or socially, and is therefore capable of being illuminated (and possibly resolved) by cost-benefit analysis.  This paper has sought to do so and the conclusions are as follows.

Firstly, opposition to covid-19 vaccines is rational for many people.  In particular, the risks of death from covid-19 if infected are so low for healthy adults under the age of 50 (less than 1/50,000) that such people could rationally prefer not to be vaccinated purely on the basis of the number of serious side-effects from the vaccine that have been reported to date by Medsafe. Secondly, if the adverse impact of mandating on those objecting to vaccination were as small as a reduction in their quality of life of 1% per year for a period of five years, mandating would only be justified if failure to do so led to a pool of unvaccinated people whose existence induced at least 5,200 additional deaths from covid-19 amongst the vaccinated.  Thirdly, this figure of 5,200 is implausibly high even if the unvaccinated were entirely responsible for infections amongst the vaccinated.  This implies that mandating is not warranted.  Fourthly, if the adverse impact of mandating on those objecting to it were larger than a reduction in their quality of life of 1% per year for a period of five years, then mandating would be even less justified.  Fifthly, unlike the general population, health workers come into frequent and close contact with large numbers of sick people, who are prime targets for covid-19, and therefore vaccine mandating may be justified for these workers.  Finally, this rationale does not apply to education workers, who are even less likely than the general population to come into close and frequent contact during their work hours with people at risk from covid-19.

  

References

Beaudet, A., Clegg, J., Thuresson, P., Lloyd, A., and MacEwan, P., (2020).  “Review of Utility Values for Economic Modelling in Type 2 Diabetes”, Value in Health, vol. 17, pp. 462-470, https://www.valueinhealthjournal.com/article/S1098-3015%2814%2900054-0/fulltext.

Best Practice Advocacy Centre, 2012. “Recommended Vaccinations for Staff Working in Primary Health Care, https://bpac.org.nz/bpj/2012/december/docs/bpj_49_upfront_pages_4-7.pdf.

Ioannidis, J., 2021.  “Reconciling Estimates of Global Spread and Infection Fatality Rates of COVID-19: An Overview of Systematic Evaluations”, European Journal of Clinical Investigation, vol. 51 (5), pp. 1-13, https://onlinelibrary.wiley.com/doi/10.1111/eci.13554.

Lally, M., 2021a.  “Analysis of the Cost Benefit Advice on Covid-19 Received by the New Zealand Government”, https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3947437.

_______ 2021b, “The Costs and Benefits of COVID-19 Lockdowns in New Zealand”, https://www.medrxiv.org/content/10.1101/2021.07.15.21260606v1.article-info.

 Medsafe, 2021a.  “Adverse Events Following Immunisation with COVID-19 Vaccines: Safety Report #35 – 30 October 2021, https://www.medsafe.govt.nz/COVID-19/safety-report-35.asp.

_______ 2021b, “Adverse Events Following Immunisation with COVID-19 Vaccines: Safety Report #32 – 9 October 2021, https://www.medsafe.govt.nz/COVID-19/safety-report-32.asp#analysis.

Meyerowitz-Katz, G., and Merone, L., 2020.  “A Systematic Review and Meta-Analysis of Published Research Data on COVID-19 Infection Fatality Rates”, International Journal of Infectious Diseases, vol. 101, pp. 138-148.

Ministry of Health, 2020, The Cost and Value of Employment in the Health and Disability Sectors, https://www.health.govt.nz/system/files/documents/publications/cost-value-employment-health-disability-sector-25nov2020.pdf.

Mood, A., Graybill, F., and Boes, D., 1974.  Introduction to the Theory of Statistics, 3rd edition, McGraw-Hill, New York.

Nordstrom, P., Ballin, M., and Nordstrom, A., 2021.  “Effectiveness of Covid-19 Vaccines Against Risk of Symptomatic Infection, Hospitalisation, and Death up to 9 Months: A Swedish Total-Population Cohort Study”, https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3949410.

Pollack, F., Thomas, S., and Kitchin, N., 2020.  Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine”, The New England Journal of Medicine, vol. 383 (27), pp. 2603-2615, https://www.nejm.org/doi/pdf/10.1056/NEJMoa2034577?articleTools=true.

Steyn, N., Plank, M., Binny, R., Hendy, S., Lustig, A., and Ridings, K., 2021a.  “A COVID-19 Vaccination Model for New Zealand”, working paper, Te Punaha Matatini, https://www.tepunahamatatini.ac.nz/2021/06/30/a-covid-19-vaccination-model-for-aotearoa-new-zealand/.

Steyn, N., Plank, M., and Hendy, S., 2021b.  “Modelling to Support a Future COVID-19 Strategy for New Zealand”, working paper, Te Punaha Matatini, https://www.tepunahamatatini.ac.nz/2021/09/23/modelling-to-support-a-future-covid-19-strategy/.

Verity, R., Okell, L., and Ferguson, N., 2020.  “Estimates of the Severity of Coronavirus Disease 2019: A Model-Based Estimate”, The Lancet, vol. 20 (6), pp. 669-677, https://www.sciencedirect.com/science/article/pii/S1473309920302437

Footnotes

[1] The costs that the unvaccinated impose upon themselves (in the form of an increased risk of death from covid-19) are not relevant here, because the unvaccinated have chosen to bear those risks.

[2] See https://www.worldometers.info/coronavirus/coronavirus-age-sex-demographics/.

[3] This comparison assumes that every unvaccinated person will be infected with covid-19 and the vaccine grants complete protection against covid-19.  Neither assumption is true, but recognition of them would raise the threshold age below which vaccination is not optimal.  In addition the figures given in the table are averages for each band, so 1/48,000 corresponds to a 45 year old, 1/11,000 to a 55 year old and therefore 1/50,000 would equate to approximately a 45 year old.

[4] As previously noted, the figures given in the table are averages for each band, so 1/48,000 corresponds to a 45 year old, 1/11,000 to a 55 year old, and therefore 1/50,000 would equate to approximately a 45 year old.

[5] Medsafe is the New Zealand Medicines and Medical Devices Safety Authority (a government entity).

[6] As previously noted, the figures given in the table are averages for each band, so 1/48,000 corresponds to a 45 year old, 1/11,000 to a 55 year old, and therefore 1/28,000 would equate to approximately a 50 year old.

[7] For example, see https://www.stuff.co.nz/national/health/coronavirus/126992919/farewell-and-thank-you-health-board-chief-says-goodbye-to-unvaccinated-staff.

[8] See https://covid19.govt.nz/alert-levels-and-updates/covid-19-protection/.  Interestingly, prior to covid-19, vaccines were not mandated in New Zealand for any contagious disease: see BPAC (2012, page 5).

[9] See https://www.statista.com/statistics/436395/age-structure-in-new-zealand/.

[10] Interestingly, the New Zealand public health system suffered excess demand even before covid-19, and this excess demand is aggravated by the poor life style choices of many people, but discrimination against them of the type applied to vaccine objectors has never been contemplated.

[11] Steyn et al (2021a, page 14) cites age-related IFR data from Verity et al (2020, Table 1) and matches it to the New Zealand population proportions by age groups, which implies an IFR of 0.95%.  The same data can be used to estimate the IFR for the 12+ group, at 1.13%.  Both figures are unreliable because they are based upon IFR data from March 2020 from only one paper (Verity et al, 2020) rather than from recent surveys of the literature (as with Ioannidis, 2021 and Meyerowitz-Katz and Merone, 2021).  However, the increase of 19% (0.95% to 1.13%) can be applied to the preferred IFR estimate for the entire population of 0.5%, to yield 0.6% for the 12+ group.

[12] In fact, it is not even certain that the vaccine reduces transmission.  In a recent High Court case, brought by four border workers who were dismissed for failure to vaccinate, evidence on this matter was presented by both parties and the judge concluded that this issue was uncertain despite being otherwise well disposed to evidence presented by the Crown and ruling in their favour: see https://www.courtsofnz.govt.nz/assets/Uploads/2021-NZHC-3012.pdf at paras 100-112.

NZ Constitutional Reform—The Need of Our Times

Guy Hatchard PhD, December 9 2021

Sometimes in life we find ourselves at a moral crossroads. On the path of our development as a nation that point has now arrived for New Zealand. No one should think that the failure of our governmental system, which has just happened, will not impact their life and that of their children. A bond of trust between our government and us has been broken. Our parent’s generation knew that once discriminatory laws that disenfranchise whole sections of society are passed a precedent has been set. Loss of profession, freedom of movement, housing, income, education, and personal medical choice for many of us invoke the darkest days of the last century. This government has crossed its Rubicon. How soon will it be before other discriminatory laws are passed? Something has to be done.

Two years ago, full of confidence, we voted into power a government who had promised us a more caring and intelligent future. It was not to be. Why?

What we didn’t know or had forgotten:—

Concepts of national law in cultures all around the world were originally derived from philosophical ideas of Natural Law and/or God’s will. The idea is that people everywhere are subject to universal laws of nature. For example, the sun shines on everyone equally. It gives life to all. Thus early concepts of the rule of law assumed that the king would be just and benevolent as they considered nature to be. As time went on confidence in the benevolence of rulers gave way to an acceptance of the need for shared responsibility. In 13th century England, Baron Simon De Montfort called together two parliaments. The first stripped King Henry III of unlimited powers and the second enfranchised citizens in the towns.

From then on parliamentary systems evolved with more checks and balances on the exercise of governmental executive authority and the legislative power vested in parliaments. The intention of these is to avoid parliamentary overreach and exclusion of the interests of minorities and stakeholders, and to provide a measure of continuity of responsibility beyond that afforded by the short elective term of parliaments such as ours.

It has also been considered very necessary to have an independent judiciary. This was achieved in the UK through the concept of common law—what is naturally fair between persons, and between the individual and the state. In the USA this was achieved through a written constitution. Being a young democracy, New Zealand initially relied on the British courts for determinations of common law. When we broke from the British Privy Council in 2004, we left behind some of the checks and balances in British common law. We didn’t realise it at the time, but this has left the NZ political system vulnerable to undue influence and manipulation.

Key weaknesses in the NZ system include:

  • Parliament is supreme. 62 newcomers can pass any law without reference to any longstanding body of wisdom.
  • The NZ Bill of Rights is advisory only—we have no rights other than those granted to us by whomsoever happens to be in the majority this week.
  • We don’t have a formal written constitution—leaving the door open for the abuse of power.
  • Because of parliamentary privilege politicians are not obliged to speak the truth and there are no mechanisms such as impeachment to hold them to account for lying.
  • The judiciary serves the dictates of Parliament—there is little reference to universal standards of fairness.
  • Control of much of our economy and the media is in the hands of foreign entities who wield subtle influence on government.
  • Levels of party allegiance and conformity restrict independent discussion.

Jacinda Ardern’s Labour government did not win a mandate to upend our Kiwi values, but they chose to do so in the form of the divisive covid legislation. They did not win a mandate for social control, but they have begun manipulating information as in their assurances of covid vaccine safety and effectiveness in the face of clear evidence to the contrary.

Immediate fixes that avoid social disruption are possible: 

  • The NZ Bill of Rights could be ‘entrenched’ as a constitutional provision that is beyond the reach of parliament alone to alter. This will strengthen the individual rights that the judiciary can protect.
  • The control exercised by party whips can be reduced to allow MPs to vote more often according to conscience. For example by reducing the MMP threshold to one per cent.
  • Parliamentarians should not be allowed to tell lies once they step outside the debating chamber, but should be subject to the same laws as anyone else.
  • Provisions of direct democracy such as those in Switzerland can be introduced and implemented through the use of modern technology.
  • Options for choices in health and education need to be strengthened.

A NZ constitutional conference should be called to discuss these and other issues which would strengthen our democratic institutions.

Contact person: Guy Hatchard PhD  094372012 0226367760

Covid-19 statistics are routinely exaggerated, and too few people care

A feature of the covid-19 pandemic has been the relentless highlighting of cases, hospitalisations and deaths of covid-19 with very little context to help interpret the statistics. No matter what the mitigating factors, the story of a deathly and fearful virus is maintained by authorities, media and others protecting  the concept of a Covid-catastrophe. This, to our knowledge, has never occurred with any other disease in living memory.

The phenomena has even exaggerated the threat of the virus in the minds of academics and health specialists, who you would expect to remain sober. As an example, Professor Rod Jackson, a professor of epidemiology, in a NZ Herald article published August 18 2020. In the article, he claimed “Learning to live with Covid-19 is not a viable option.”

Jackson made several exaggerated claims of the severity of covid-19 that have gone unchallenged for 17 months. He stated that the infection fatality rate of the virus was between 0.5% and 1.5%, or about 1%. He stated that covid-19 is 20 to 40 times worse than the seasonal flu and that one in five infections (20%) would be hospitalised, and that one in five who were hospitalised would require intensive care. That means 4% of hospitalised cases will require intensive care (1/5 * 1/5 = 1/25 = 4%).

In reality, the proportion of cases requiring hospitalisation in New Zealand, at the time of writing (25/11/2021) is ~57/5213 cases = 1%. This is a 20-fold difference in risk of hospitalisation after testing positive for covid-19, comparing Jackson’s estimate to Ministry of Health reports. Rather than a 4% risk of need for intensive care, the risk is now 7 in intensive care/5,213 current cases = 1.3/1,000 or 0.13%.

The difference in severity of covid-19 conveyed by Professor Jackson compared to observed data may be displayed in Euler diagrams consisting of concentric circles whose areas represent numbers in each category of severity below (figure 1 for Jackson’s estimates, figure 2 for current government figures and figure 3 for pre-vaccine era figures). In each figure, the area of the outer circle is proportional to the total count of covid cases, the grey indicate those who needed hospital treatment, the light blue intensive care and the red deaths (taken as 1% case-fatality for Professor Jackson, and estimated by using 5,213 current cases * 41 deaths/10,789 cumulative cases in New Zealand (11/November/2021)).

These diagrams demonstrate the distorted perspective portrayed by experts and health authorities, compared to the official reported reality. The difference is stark.

Figure 1. Professor Jackson’s estimated proportions of cases needing hospitalisation, intensive care and who would ultimately die with covid-19 in the New Zealand media, August 2020.

Notional 10,000 cases used for illustration.

Figure 2. Actual severity of covid-19 cases in New Zealand, 25/Nov/2021.

One possible explanation for this discrepancy is that covid-19 cases in New Zealand now are mitigated by the widespread use of the vaccine. However, figure 3 below is based on an earlier description of the epidemiology of New Zealand covid cases from February to May 2020, before the vaccine era. This indicates only 4%, rather than Jackson’s 20% of cases needed treatment in hospital. Reality was already five times lower than Jackson’s figure. The admissions to intensive care were 0.67% of all cases, six times lower than Jackson’s estimate. Also, one can see (figure 2) that the many of the apparent deaths with covid-19 did not qualify for intensive care treatment, due to age and comorbidity. The figures given by Jackson have never been questioned for accuracy or corrected. Jackson also talked of infections rather than ‘cases’, on which the Lancet paper he drew from was based. This means the reality departs even further than Jackson’s depiction indicates.

Figure 3. Severity of covid-19 cases in New Zealand, February to May 2020.

To make sound policy, supported by a well-informed public, health authorities, and the media must convey an accurate sense of the severity of covid-19.

The threat needs to be estimated from true counts, rather than conjured-up figures. The diagrams convey how far reality has been warped.

It is clear now that many predictions, models, estimates and beliefs did not come to pass. The investment in the famed ‘elimination strategy’ is now not worth the paper it was written on. The lack of scrutiny on doomsday predictions has adversely affected our perception of the reality of covid-19 and our collective ability to respond to it appropriately.

We’ve been wondering why this distortion is occurring, and why so few people seem to care. The factor that stands out to us, and that the case of Professor Jackson illustrates, is that no one loses by highlighting the worst and downplaying the best. There are no questions, no re-assessments, and no penalties for being wrong, if you follow and contribute to the story of a deadly virus.

Withdrawn paper related to the risk of miscarriage in pregnancy after covid-19 vaccination

Simon Thornley, Aleisha R. Brock.

17/11/2021

Re: Brock AR and S Thornley. 2021. Rapid Communication Spontaneous Abortions and Policies on COVID-19 mRNA Vaccine Use During Pregnancy. Science, Public Health Policy & the Law 4:130-143.

 

As the authors of the above paper, we have asked the publisher to withdraw it. This is because it has the alarming statistic “Our re-analysis indicates a cumulative incidence of spontaneous abortion 7 to 8 times higher than the original authors’ results (p < 0.001) and the typical average for pregnancy loss during this time period”. This calculation is not justified and does not represent the true risk of miscarriage given exposure to the vaccine in early pregnancy.

In our re-analysis, a calculation was made from an ambiguous description of the methods of the original article1 and as such the true incidence of spontaneous abortions in those exposed to mRNA vaccines prior to 20 weeks’ gestation could not be accurately estimated. This occurred due to a short study duration (11-weeks) and no active follow-up in these groups by the conclusion of the study. This resulted in an overestimated calculation of 82-91% or 7-8 fold increase in spontaneous abortions. This overlooked the 1,132 women exposed in the first trimester, who would not have registered a completed pregnancy by the end of the study. Of the 104 miscarriages, 96 occurred in the first trimester and 8 in the second trimester. This means the miscarriage cumulative incidence was 104/1,132 or 9.2%.

A follow-up publication based on the same cohort quotes a cumulative incidence of miscarriage of 14.1%.2 This is considerably lower than the 7 to 8 fold increase that we calculated. There are a range of background miscarriage rates quoted in comparable studies before the covid-19 era which range from 5.4%3 to 21.3%.4 Of note, another case-control study from Norway shows no increased risk in exposure to covid-19 vaccination, comparing women with a first trimester miscarriage to those with a first trimester pregnancy.5

From this evidence, we withdraw the recommendation that covid mRNA injections be considered ‘category X’, but rather suggest caution with their use, in consideration of the overall risks of covid-19 infection in pregnancy.6 We unreservedly apologise for any alarm caused by the publication of the paper.

References

1. Shimabukuro TT, Kim SY, Myers TR, et al. Preliminary findings of mRNA Covid-19 vaccine safety in pregnant persons. New England Journal of Medicine 2021;384(24):2273-82.

2. Zauche LH, Wallace B, Smoots AN, et al. Receipt of mRNA Covid-19 vaccines and risk of spontaneous abortion. New England Journal of Medicine 2021;385(16):1533-35.

3. Naert MN, Khadraoui H, Muniz Rodriguez A, et al. Stratified risk of pregnancy loss for women with a viable singleton pregnancy in the first trimester. The Journal of Maternal-Fetal & Neonatal Medicine 2020:1-7.

4. Mukherjee S, Velez Edwards DR, Baird DD, et al. Risk of miscarriage among black women and white women in a US Prospective Cohort Study. American Journal of Epidemiology 2013;177(11):1271-78.

5. Kharbanda EO, Haapala J, DeSilva M, et al. Spontaneous Abortion Following COVID-19 Vaccination During Pregnancy. Journal of the American Medical Association 2021;326(16):1629-31. doi: 10.1001/jama.2021.15494

6. Son M, Gallagher K, Lo JY, et al. Coronavirus Disease 2019 (COVID-19) Pandemic and Pregnancy Outcomes in a U.S. Population. Obstetrics and Gynecology 2021;138(4):542-51. doi: 10.1097/AOG.0000000000004547

Fact checking the RNZ fact check

17/11/2021

Radio New Zealand has recently criticized a Facebook live conversation between former National MP Matt King and epidemiologist Dr Simon Thornley. While people should undertake their own research, we provide some comments related to the media’s critique. The evidence related to covid-19 policy continues to change and be updated.

In the interview, Professor Rod Jackson made several claims, decrying Thornley personally during the interview. Let’s examine them in turn.

  1. “There is no trial evidence that ivermectin [an anti-parasitic drug used as early treatment for covid-19 in some parts of the world] works in people with Covid – it doesn’t exist.”

Trials do exist. In fact a meta-analysis or summary study of six such trials exist. The pooled effect of these trials is a 79% decline in all-cause mortality (95% confidence interval: 89% to 58%). These trials are from Iraq, Iran, Bangladesh, Egypt, Turkey and India, places less reticent about its use. But they are trials, and the reduction in all-cause mortality is stark, an endpoint which is generally considered clinically important and free of error and bias. Another trial points to effective treatment, such as from vitamin D supplementation, which reduced intensive care admissions to 1/50 (2%) in the treated from 13/26 (50%) in the untreated in Spanish covid-19 patients.

We’re not advocating ivermectin at all. But we are prepared to look at the evidence. The fact that Jackson didn’t know there were trials invalidates his point.

  1. “Professor Jackson also said claiming Covid-19 was no worse than the flu was nonsense”.

In the interview, Thornley claimed the infection fatality rate of covid-19 was as bad as a ‘severe flu’. A summary study of many countries indicates that the average global infection fatality rate of covid-19 is 0.15% or 1/667 people.

The fatality rate for H1N1 influenza is variable, but this figure from covid-19 is well within the range of estimates presented from a similar summary study.

The comparison between covid-19 and flu is therefore fair and accurate. Jackson’s claim is misinformation.

We should note that many fatality studies take the definition of a covid-19 death at face value but it does not mean the individual died exclusively from the virus. This was exemplified by the counting a recent covid-19 death in a man who was actually shot and killed, yet tested positive for SARS-CoV-2 during the autopsy. This was defended by the Ministry of Health, as it conformed with World Health Organization policy.

We are able to test the accuracy of Jackson’s claimed fatality risk. In May 2020, Jackson admonished Sweden for its lax approach. He said the fatality rate of covid-19 was 1/100 people infected, so predicted 56,000 deaths from covid-19 in the country, assuming 60% of the population would be infected. To date, there have been about 15,000 covid-19 deaths, with an age distribution similar to that of background deaths (figure). In fact, by all accounts, Sweden has fared through the epidemic particularly well compared to other European countries.

Figure. Deaths with covid-19 in Sweden, by age at November 3, 2021.

Source: statistica.com

  1. “This is a severe disease and we have a evidence-based treatment [the vaccine] where there is definitive evidence that it reduces the risk of severe disease and death by 95 percent, in that order.”

This is an extraordinary claim for several reasons. First, the original Pfizer trial reported about the same number of overall deaths in the treated and the untreated groups (14 in the treated and 13 in the untreated). In the six-month trial results, only three covid-19 deaths occurred, one in the treated and two in the untreated group. This is not consistent with Jackson’s assertion of a 95% reduction in risk of severe disease and death.

Given the numbers of deaths in the original trial, it is possible to work out whether the trial would have picked up a 95% reduction as Jackson claims. The trial would have been expected to have only one death in the treated group, and would have detected a difference more than expected by chance with 96% certainty.

There is observational evidence from Sweden of reduced covid-19 hospitalisations and deaths (not from all-causes), however, the vaccine effect diminished to zero for all three outcomes eight months after the date that the vaccine was administered.

To compound the confusion about the effect of the vaccine, the original Pfizer trial now is marred by whistle-blowers who have given the British Medical Journal evidence of fraud occurring during its conduct. Sixteen Swedish doctors have now called for the injection to be suspended as a result of these revelations.

Both Jackson and RNZ use extensive use of ad hominem attacks, which are considered an invalid, and lowest, form of argument.

Examples include:

  • “anti-vax”
  • “discredited academic”
  • “And we have someone who is questioning that evidence, who doesn’t know what they’re talking about, talking to an epidemiologist who doesn’t know what he’s talking about.”
  • “outlier in his field”.

The purveyors and writers of such ‘argument’ appear to have no embarrassment at the anti-intellectualism and inhumanity of their conduct.

We’ll stick to the contest of ideas by again considering Jackson’s accuracy. Back in August 2020, Jackson and his colleagues claimed that elimination was still the best strategy for New Zealand to tackle covid-19. That article has not dated well, yet the personalised tirade and arguments are familiar.

“He [Thornley] is the only dissenter in the epidemiological community,”

“It’s not like this is a discussion like a boxing match with two equal partners. What you’ve got is every experienced epidemiologist in the country supporting the Government’s elimination approach.”

“We are all advising the Government, and we speak with one voice. And you have got a junior epidemiologist who is presenting a different case.”

Jackson has made increasingly inaccurate claims during the pandemic, claiming, unchallenged that one in five infected people will be hospitalised after infection with covid-19. No media have ever fact checked this.

New Zealand’s own government data shows Jackson  overestimated by at least a factor of ten, since the proportion of cases (rather than infections) hospitalised is 2% (table).

Table. Counts of cases of covid-19 in New Zealand (16 November 2021).

Count %
Self-isolation 2058 56%
Isolation Complete 969 26%
Managed Isolation 396 11%
Hospital 73 2%
Other 198 5%

 

As sailing great Russell Coutts has recently pointed out, it is questionable how “media entities can maintain objectivity when they have accepted a government grant that is conditional on them promoting certain government policies”.

It is prudent to check all sources of information, not only those who dare to question the what is coming from the Beehive.

Should caution be exercised in the rollout of covid-19 vaccines to NZ children from 5 years old? History indicates rushed decisions lead to regret.

Should caution be exercised in the rollout of covid-19 vaccines to NZ children from 5 years old? History indicates rushed decisions lead to regret.

Gerhard Sundborn,1* Simon Thornley,2 Rupert Scott,3 René de Monchy,4 Matt Shelton,5 Byram Bridle6 

 

Lecturer in Pacific Health, University of Auckland, Department of Pacific Health, New Zealand 1

Epidemiologist/Public Health Physician, University of Auckland, Section of Epidemiology and Biostatistics, New Zealand 2

General Practitioner, Whangarei, New Zealand 3

General Practitioner and Psychiatrist, Tauranga, New Zealand 4

General Practitioner, Wellington, New Zealand 5

Professor of Viral Immunology, University of Guelph, Canada6

Corresponding author * email: g.sundborn@auckland.ac.nz

 

The New Zealand Ministry of Health have indicated that they are now actively considering the Pfizer covid-19 vaccine for New Zealand Children age from 5 to 11 years old.1 This follows its approval for use in New Zealand children aged 12 to 15 years on Monday 21st June, by ‘Medsafe’, New Zealand’s drug regulator.2 Other countries including USA, Canada, China and the European Commission who have also approved the vaccine for children aged 12 to 15 years old. China has authorised vaccination for children from three years of age. However, the World Health Organization (WHO) advise that children and adolescents have milder disease than adults and therefore more evidence is needed on different covid-19 vaccines for this age group, which has prevented them from making general recommendations for their use.3 In the UK  the Joint Committee on Vaccination and Immunisation (JVCI) concluded that the health benefits gained by vaccination of 12 – 15 year old children are only marginally greater than the potential and known harms. And that this margin of benefit was too small to support universal vaccination of healthy 12 to 15 year old children.4 Since covid-19 itself poses little risk of fatality to children, and the exposure to a vaccine entails risks which are now poorly understood, we examine them in more detail here. Recently, an Auckland Professor of Epidemiology, regarding covid-19 vaccination stated:

“The Government has introduced (vaccine) mandates in health – total no-brainer. They’ve also introduced one in education for all the staff – total no-brainer. They need to introduce the same mandate for 12-and-over children”.5

To date, a decision to rollout the vaccine to children aged 5 – 11 years has not been made. We question the idea that vaccine mandates are a “no-brainer” particularly for children. Specifically, we believe that for children, emerging data indicates that such a policy will lead to more harm than good. We urge a precautionary approach be taken and that any plans for the vaccination of children be delayed for three important reasons.

Long-term safety and efficacy of the covid-19 vaccine is unknown: The first and most crucial point is that the long-term safety and efficacy data from the trial will not be available until 2023. Although short-term safety and efficacy data looks promising, this has only been tested in a small cohort of children, with 1,131 children receiving the vaccine at the time of writing.6 This means that detected adverse effects would only be those which are relatively common, and side effects, such as excess clotting that have led to the withdrawal of the AstraZeneca vaccine, for example, from many countries would not have been detected.7 This vaccine is one of the fastest to ever be developed and rolled out, taking less than one calendar year. Before this, the fastest approval was four years. Most take an average of ten to fifteen years from development to approval for clinical use.8

When we reflect on the 2009 swine flu pandemic a similar scenario occurred where the hastened development and approval of a vaccine took an astonishing 5-6 months once the new virus was identified.9 The vaccine was then administered widely, until 2011-12 when long term safety and efficacy data were available – from which studies indicated that the vaccine caused unacceptable rates of narcolepsy.10 This resulted in over a billion-dollars’ worth of these vaccines being destroyed.11-13

Another more distressing example occurred in the 1976 swine flu outbreak at the US Fort Dix military base. The infection caused one death and 230 soldiers to become ill. This led to a hastily developed vaccine that was rolled out to approximately 22% of the US population. The resulting vaccine caused over 500 cases of paralysis and 25 deaths. The vaccine was far worse than the virus itself and observers thought that the government response was too fast, with important safety considerations overlooked.14

In the US there has been a dramatic increase observed in US government vaccine injury reports as evidence of vaccine harm. The 100-fold increase in post-vaccine deaths reported in temporal association to the rollout of the Covid-19 vaccines in late 2020 is perhaps best shown in the plot below.

Figure 1. Time series of monthly reports of post-vaccine deaths to the US VAERS monitoring system.

Such a rapid increase in reports should be cause for concern, particularly when the development and clinical testing of the vaccines has been so truncated, and adverse effects from wide scale vaccination are unknown.15  Conventional epidemiological knowledge confirms that medical adverse event databases generally under-report safety signals. In a United States study that compared augmented electronic monitoring of health records in the thirty days post-vaccination, with prompting of clinicians to report likely vaccine-related events to usual practice, the augmented system resulted in a 30-fold increase in vaccine-related incident reporting, compared to historical periods. 16 When considering whether the spike in adverse event reporting is related to increased rates of vaccination or harm due to the vaccine, statistical tests carried out by Rose et. al. indicate clearly that the deaths are clustered around the time immediately after the event, in a manner which is incompatible with what would be expected if such deaths were occurring due to background mortality risks (P < 0.001).17

Efficacy of the Pfizer covid-19 vaccine is reported to be 52% after the initial dose and 95% after the second dose which has been taken from interim data.18 However, these claims have been questioned by researchers in Israel who have seen a far lower than expected decline in cases following vaccination of over 75% of their elderly population. Rather than a 52% decline in cases they have seen a significantly lower reduction in cases by 33%.19 Further, the protection against new variants of the virus remains unknown. A study recently published in the Lancet has found being fully vaccinated does not reduce any transmissibility once infected with the virus, compared to unvaccinated infected people.20

 

Very recently published evidence from overseas, where the vaccine rollout has occurred earlier than in New Zealand shows that vaccines are not resulting in enduring and lasting protection from the virus. A preprint Swedish cohort study (1.6 million people) which compares the risk of Covid-19 infection in vaccinated and unvaccinated people throughout the Covid-19 vaccination roll-out in the country from the 4th of January to the 4th of October 2021.21  Analysis of those who had taken the Pfizer vaccine showed that the effectiveness at preventing symptomatic infection waned from initial high levels to 47% in the period 121-180 days after the vaccine to no convincing effect beyond day 211 post-vaccination (23% reduction; 95% confidence interval, -2 to 41, P = 0·07), compared to unvaccinated people. This modelled decline in vaccine effectiveness is illustrated in the figure below. Such an effect was observed for all Covid-19 vaccinations used in the country, and observed for more severe health outcomes such as prevention of Covid-19 hospitalisation and death.

Figure 2. Estimated adjusted effect of vaccine to prevent Covid-19 infection after vaccination in Sweden.21 Solid line represents point estimate and shading represents 95% confidence interval. Overall, no beneficial effect is observed after 240 days (8 months) since vaccination.

The risk covid presents to children is negligible: The second reason against vaccinating children is the very small risk that the virus poses to this group.22 There is a 1,000-fold difference in mortality risk between comparing children with frail elderly people after testing positive for covid-19. It is extraordinarily rare for a child to suffer any significant illness from covid-19 and orders of magnitude more rare for them to die from this virus.23 A prominent US epidemiologist likened the risk of a person less than 65 years old dying from covid-19 as remarkably uncommon and about the same as dying during a car journey from between 21 – 162 km each day.24 This comparison shows that there is little personal risk posed by covid-19 to children and thus no reason to expose them to an experimental vaccine. Other arguments for vaccinating children are related to the threat of ‘asymptomatic transmission’. Up-to-date evidence, however, shows little evidence of this phenomenon in Wuhan, after 10 million people were screened by PCR for infection, whether or not they had symptoms.25

Vaccine-associated risks that need further investigation: To date 18 countries including Canada, Sweden, Latvia, Germany, Italy, France, Spain, Denmark, Norway, and The Netherlands, have halted the roll-out of the AstraZeneca covid-19 vaccine due to concerns that it has caused blood clots in some recipients.6 There are similar concerns that the Pfizer vaccine may also cause clots. In Norway, 23 deaths of frail elderly people occurred shortly after receiving the Pfizer vaccine – with an investigation concluding that the vaccine was responsible for at least 10 of these deaths.26 In Australia two middle-aged women also died after receiving the AstraZeneca vaccine, caused by rare blood clots in the brain.27

Another risk from the vaccine for young people that have received the Pfizer or Moderna vaccine is myocarditis or pericarditis. In the US, more than 1,200 such cases have been identified in people younger than thirty years according to the Centres for Disease Control. A study in the United States showed that the risk of myocarditis after vaccination was 3.7 to 6.1 times higher than the risk of hospitalisation due to covid-19, even under conditions of moderate and high covid-19 incidence.28     A more recent study shows a 13.6-fold (1,260%) increase in new cases of myocarditis after the second vaccine in 16 to 19 year old males, compared to background rates of the disease in the same demographic group between 2017 and 2019.29 Other authors have questioned the use of vaccines in anyone less than the age of 65 years, since deaths attributable to the vaccine are likely to outnumber those saved by a factor of five.30 For younger children, this calculation is even less favourable. These events have generally occurred within a week following receiving the second dose of the vaccine.31

Under-reporting into vaccine safety databases is common. In a United States study that compared augmented electronic monitoring of health records in the thirty days post-vaccination, with prompting of clinicians to report likely vaccine-related events to usual practice, the augmented system resulted in a 30-fold increase in vaccine-related incident reporting,32 compared to historical periods. This means that analyses based on such reporting systems are likely to be gross underestimates of the true burden of adverse events.

Other academics overseas have expressed concerns at the high rate of post-vaccine adverse effects reported in vaccine safety databases. In the UK ‘Yellow card’ system, for example, between 4 Jan and 26 May 2021, a total of 1,253 deaths and 888,196 adverse reactions post covid-19 vaccine were recorded, with 63 million people receiving at least one dose, and 24 million having had two doses.  This is roughly a 1/50,000 risk of death and 1/70 risk of adverse reaction after vaccination, assuming these reports are all caused by the vaccine. The author of the document, Dr Tess Lawrie, stated that based on these figures there was: “more than enough evidence … to declare the COVID-19 vaccines unsafe for use in humans”.33

Table 1. Adverse Events for Covid-19 Pfizer vaccine verses influenza vaccine in NZ

  Covid-19

Vaccine

2021

 Influenza Vaccine 2019
Adverse Events Following Vaccination

(AEFI)

 27,651 229
AEFI Rate 477/100,000 15.2/100,000
Adverse Events of Special Interest 982 –
Death following vaccination 91 –
Doses administered 5,792,114 1,505,268

Reviewing the latest Covid-19 vaccine safety report from Medsafe (New Zealand Medicines and Medical Devices Safety Authority) published on 9 October 202134 – a total of 27,651 Adverse Events following Vaccination (AEFI) have occurred. With 982 of these being Adverse Events of Special Interest (AESI) which are paid greater attention due to their seriousness. Most concerning is the number of deaths that have occurred following vaccination which now totals 91. When comparing the number of adverse events from the covid-19 vaccine to those reported to Medsafe for the influenza vaccine in 2019, 35 we calculate that the Covid-19 vaccine adverse events rate is more than 31-fold greater. Further the influenza vaccine has no reports of Adverse Events of Special Interest, nor death following vaccination. From these data the covid-19 vaccine exposes those who receive it to far higher rate of adverse health consequences than that for influenza.

Summary: The Pfizer covid-19 vaccine remains experimental and is only provisionally approved for use in New Zealand. Long-term safety and efficacy data will not be known until 2023, and children are largely unaffected by the virus. Like the swine flu vaccine, a true understanding of the long-term side-effects of the vaccine remain unknown until these trials are complete. There are several serious side effects caused by current covid-19 vaccines whose risks are not fully understood. Basic safety biodistribution studies are missing,36 with data from rodent models showing high uptake of nanoparticle delivery substrate in the ovaries of these animals.37 Basic safety studies, that are a routine part of vaccine development were not carried out for this vaccine.

When considering whether to vaccinate children against covid-19, one must weigh the therapeutic benefits against the risks. With such little to gain, all children can possibly experience are the risks of the product, such as myocarditis. True estimates of risks from the vaccine are now not fully understood, although there are already several identified now including blood clots, myocarditis, and death. 38, 39, 34

On balance, we believe that the known and unknown risks from the vaccine outweigh any benefits for children. Historical examples should lead us to pause and make a sober assessment of the risks, given the lack of benefit to children. We believe that it is best to wait at least two years for the long-term safety and efficacy results to enable a more informed decision to be made about whether to vaccinate children against SARS-CoV-2. Whatever else can be said about the decision to vaccinate children, it cannot and must not be considered a “no brainer”. No sober analysis would come to that conclusion.

 

This research did not receive any specific funding.

The authors declare no conflicts of interest.

  

References

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5. Wilkins, Alice. Coronavirus: Expert calls for mandatory student vaccinations as senior high schoolers in level 3 return for in-person learning. Newshub. 25 October 2021. https://www.newshub.co.nz/home/new-zealand/2021/10/coronavirus-expert-calls-for-mandatory-student-vaccinations-as-senior-high-schoolers-in-level-3-return-for-in-person-learning.html

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10. Stranden AL. Norwegian study links flu vaccine to narcolepsy risk [Internet]; Science Norway, 28 March 2017; [cited 2020 Dec 17]. Available from: https://sciencenorway.no/forskningno-norway-vaccine/norwegian-study-links-flu-vaccine-to-narcolepsy-risk/1444067

11. Conner R. Germany to destroy expensive, unwanted swine flu vaccine [Internet]; Deutsche Welle, 17 August 2011; [cited 2020 Dec 17]. Available from: https://www.dw.com/en/germany-to-destroy-expensive-unwanted-swine-flu-vaccine/a-15324186

12. O’Callaghan T. Some 40 million doses of H1N1 vaccine to be destroyed [Internet]; Time, 1 July 2010; [cited 2020 Dec 17]. Available from: https://healthland.time.com/2010/07/01/some-40-million-doses-of-h1n1-vaccine-to-be-destroyed/

13. Independent. Netherlands destroying 17 million swine flu vaccine doses [Internet]; 18 September 2011; [cited 2020 Dec 17]. Available from: https://www.independent.co.uk/life-style/health-and-families/netherlands-destroying-17-million-swine-flu-vaccine-doses-2038287.html

14. Khamsi, Roxanne. How we will know when coronavirus vaccine is ready. [Internet] National Geographic. 1 July 2020. [cited 2021 July 7] Available from: https://www.nationalgeographic.com/science/2020/06/how-we-will-know-when-coronavirus-vaccine-is-ready-cvd/

15. Seneff et al “Worse Than the Disease? Reviewing Some Possible Unintended Consequences of the mRNA Vaccines Against COVID-19”  Vol. 2 No. 1 (2021): Epidemic NCDs https://www.ijvtpr.com/index.php/IJVTPR/article/view/23

16. Meghan A. Baker, David C. Kaelber, David S. Bar-Shain, Pedro L. Moro, Bob Zambarano, Megan Mazza, Crystal Garcia, Adam Henry, Richard Platt, Michael Klompas, Advanced Clinical Decision Support for Vaccine Adverse Event Detection and Reporting, Clinical Infectious Diseases, Volume 61, Issue 6, 15 September 2015, Pages 864–870, https://doi.org/10.1093/cid/civ430

17. Rose J. A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse Events Reporting System (VAERS) of the COVID-19 Messenger Ribonucleic Acid (mRNA) Biologicals. Science, Public Health Policy, and The Law. Volume 2:59-80. May, 2021.

18. Mahase E. Covid-19: Pfizer vaccine efficacy was 52% after first dose and 95% after second dose, paper shows BMJ 2020; 371: m4826 doi:10.1136/bmj.m4826

19. Mahase E. Covid-19: Reports from Israel suggest one dose of Pfizer vaccine could be less effective than expected. BMJ. 2021 Jan 22;372:n217. doi: 10.1136/bmj.n217. PMID: 33483332

20. Singanayagam A, Hakki S, Dunning J, Madon KJ, Crone MA, Koycheva A, et al. Community transmission and viral load kinetics of the SARS-CoV-2 delta (B.1.617.2) variant in vaccinated and unvaccinated individuals in the UK: a prospective, longitudinal, cohort study. Lancet Infect Dis 2021 Published Online October 28, 2021 https://doi.org/10.1016/ S1473-3099(21)00648-4

21. Nordström, Peter and Ballin, Marcel and Nordström, Anna, Effectiveness of Covid-19 Vaccination Against Risk of Symptomatic Infection, Hospitalization, and Death Up to 9 Months: A Swedish Total-Population Cohort Study. Available at SSRN: https://ssrn.com/abstract=3949410  or http://dx.doi.org/10.2139/ssrn.3949410

22. Bhopal SS, Bagaria J, Olabi B, Bhopal R. Children and young people remain at low risk of COVID-19 mortality. Lancet Child Adolesc Health. 2021 May;5(5):e12-e13. doi: 10.1016/S2352-4642(21)00066-3. Epub 2021 Mar 11. Erratum in: Lancet Child Adolesc Health. 2021 Mar 24;: PMID: 33713603; PMCID: PMC7946566.

23. Battacharya J. Opinion: Jay Bhattacharya: A compassionate covid strategy. [Internet] NWA Online. 15 November 2020. [cited 9 July 2021] Available from: https://www.nwaonline.com/news/2020/nov/15/compassionate-covid-strategy/

24. Ioannidis JPA, Axfors C, Contopoulos-Ioannidis DG. Population-level COVID-19 mortality risk for non-elderly individuals overall and for non-elderly individuals without underlying diseases in pandemic epicenters. Environ Res. 2020 Sep;188:109890. doi: 10.1016/j.envres.2020.109890. Epub 2020 Jul 1. PMID: 32846654; PMCID: PMC7327471.

25. Cao, S., Gan, Y., Wang, C. et al. Post-lockdown SARS-CoV-2 nucleic acid screening in nearly ten million residents of Wuhan, China. Nat Commun 11, 5917 (2020). https://doi.org/10.1038/s41467-020-19802-w

26. Torjesen I. Covid-19: Pfiver-BioNTech vaccine is “likely” responsible for deaths of some elderly patients, Norwegian review finds BMJ 2021; 373 :n1372 doi10.1136/bmj.n1372

27. Davey M. ‘Extremely rare’: Australia records second death ‘likely linked’ to AstraZeneca vaccine blood clots. [Internet] The Guardian. 10 June 2021. [cited 9 July 2021] Available from: https://www.theguardian.com/australia-news/2021/jun/10/extremely-rare-australia-records-second-death-likely-linked-to-astrazeneca-vaccine-blood-clots

28. Hoeg T, Krug A, Stevenson J, Mandrola J. SARS-CoV-2 mRNA Vaccination-Associated Myocarditis in Children Ages 12-17: A Stratified National Database Analysis. medRxiv preprint posted 8 September 2021. https://www.medrxiv.org/content/10.1101/2021.08.30.21262866v1.full.pdf

29. Mevorach D, Anis E, Cedar N, Bromberg M, Haas EJ, Nadir E, Olsha-Castell S, Arad D, Hasin T, Levi N, Asleh R, Amir O, Meir K, Cohen D, Dichtiar R, Novick D, Hershkovitz Y, Dagan R, Leitersdorf I, Ben-Ami R, Miskin I, Saliba W, Muhsen K, Levi Y, Green MS, Keinan-Boker L, Alroy-Preis S. Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel. N Engl J Med. 2021 Oct 6:NEJMoa2109730. doi: 10.1056/NEJMoa2109730. Epub ahead of print. PMID: 34614328; PMCID: PMC8531987.

30. Kostoff RN, Calina D, Kanduc D, Briggs MB, Vlachoyiannopoulos P, Svistunov AA, Tsatsakis A. Why are we vaccinating children against COVID-19? Toxicol Rep. 2021;8:1665-1684. doi: 10.1016/j.toxrep.2021.08.010. Epub 2021 Sep 14. Erratum in: Toxicol Rep. 2021 Oct 7;: PMID: 34540594; PMCID: PMC8437699. https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC8437699/pdf/main.pdf

31. Lovelace B. CDC safety group says there’s a likely link between rare heart inflammation in young people after Covid shot. [Internet] CNBC. 23 June 2021. [cited 9 July 2021] Available from: https://www.cnbc.com/2021/06/23/cdc-reports-more-than-1200-cases-of-rare-heart-inflammation-after-covid-vaccine-shots.html

32. Meghan A. Baker, David C. Kaelber, David S. Bar-Shain, Pedro L. Moro, Bob Zambarano, Megan Mazza, Crystal Garcia, Adam Henry, Richard Platt, Michael Klompas, Advanced Clinical Decision Support for Vaccine Adverse Event Detection and Reporting, Clinical Infectious Diseases, Volume 61, Issue 6, 15 September 2015, Pages 864–870, https://doi.org/10.1093/cid/civ430

33. Trialsite staff. Look into UK Yellow Card System Reveals Large Numbers of Adverse Events and Deaths Associated with COVID-19 Vaccine. [Internet] Trial Site News. 10 June 2021. [cited 9 July 2021] Available from:

34. https://trialsitenews.com/wp-content/uploads/2021/06/Yellow-Card-Letter.pdf

35. Medsafe. Adverse events following immunization with COVID-19 vaccines: Safety Report #32 – 9 October 2021. Published  9 October 2021. Accessed 31 October, 2020.  https://www.medsafe.govt.nz/COVID-19/safety-report-32.asp

36. Medsafe. Spontaneous reports: Seasonal influenza vaccination 2020. Revised1 April 2021. Accessed 4 October, 2020. https://www.medsafe.govt.nz/safety/reports-and-promotion/Spontaneous-Reports-Influenza-Vaccination-2020.asp#More

37. Doshi P. Covid-19 vaccines: In the rush for regulatory approval, do we need more data? BMJ 2021; 373 :n1244 doi: 10. 1136/bmj.n1244 Available from: https://www.bmj.com/content/373/bmj.n1244

38. Joan-Ramon Laporte, Ermengol Coma, Francesc Fina, Luís García-Eroles, Xavier Vidal, Manuel Medina.  Vaccines against Covid-19, venous thromboembolism, and thrombocytopenia. A population-based retrospective cohort study. MedRxiv preprint; this version posted September 5, 2021. Date accessed: 4 October 2021. doi: https://doi.org/10.1101/2021.07.23.21261036

39. Marshall M, Ferguson ID, Lewis P, et al. Symptomatic acute myocarditis in seven adolescents following Pfizer-BioNTech COVID- 19 vaccination. Pediatrics. 2021; doi: 10.1542/peds.2021-052478

Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2635 (Published 02 November 2021) Cite this as: BMJ 2021;375:n2635
  1. Paul D Thacker, investigative journalist

Author affiliations

Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports

In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1

But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.

Poor laboratory management

On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos.

Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.

In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. “In my mind, it’s something new every day,” a Ventavia executive says. “We know that it’s significant.”

Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. ICON reminded Ventavia in a September 2020 email: “The expectation for this study is that all queries are addressed within 24hrs.” ICON then highlighted over 100 outstanding queries older than three days in yellow. Examples included two individuals for which “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.” According to the trial protocol a telephone contact should have occurred “to ascertain further details and determine whether a site visit is clinically indicated.”

Worries over FDA inspection

Documents show that problems had been going on for weeks. In a list of “action items” circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jackson’s hiring, a Ventavia executive identified three site staff members with whom to “Go over e-diary issue/falsifying data, etc.” One of them was “verbally counseled for changing data and not noting late entry,” a note indicates.

At several points during the late September meeting Jackson and the Ventavia executives discussed the possibility of the FDA showing up for an inspection (box 1). “We’re going to get some kind of letter of information at least, when the FDA gets here . . . know it,” an executive stated.

Box 1

A history of lax oversight

When it comes to the FDA and clinical trials, Elizabeth Woeckner, president of Citizens for Responsible Care and Research Incorporated (CIRCARE),3 says the agency’s oversight capacity is severely under-resourced. If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. And sometimes oversight occurs too late.

In one example CIRCARE and the US consumer advocacy organisation Public Citizen, along with dozens of public health experts, filed a detailed complaint in July 2018 with the FDA about a clinical trial that failed to comply with regulations for the protection of human participants.4 Nine months later, in April 2019, an FDA investigator inspected the clinical site. In May this year the FDA sent the triallist a warning letter that substantiated many of the claims in the complaints. It said, “[I]t appears that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects.”5

“There’s just a complete lack of oversight of contract research organisations and independent clinical research facilities,” says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials.

Ventavia and the FDA

A former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial.

“People working in clinical research are terrified of FDA audits,” Jill Fisher told The BMJ, but added that the agency rarely does anything other than inspect paperwork, usually months after a trial has ended. “I don’t know why they’re so afraid of them,” she said. But she said she was surprised that the agency failed to inspect Ventavia after an employee had filed a complaint. “You would think if there’s a specific and credible complaint that they would have to investigate that,” Fisher said.

In 2007 the Department of Health and Human Services’ Office of the Inspector General released a report on FDA’s oversight of clinical trials conducted between 2000 and 2005. The report found that the FDA inspected only 1% of clinical trial sites.6 Inspections carried out by the FDA’s vaccines and biologics branch have been decreasing in recent years, with just 50 conducted in the 2020 fiscal year.7

RETURN TO TEXT

The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizer’s clinical trial at Ventavia. She then reported her concerns in an email to the agency. In the afternoon Ventavia fired Jackson—deemed “not a good fit,” according to her separation letter.

Jackson told The BMJ it was the first time she had been fired in her 20 year career in research.

Concerns raised

In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. The full trial (registered under NCT04368728) enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres. She then listed a dozen concerns she had witnessed, including:

  • Participants placed in a hallway after injection and not being monitored by clinical staff

  • Lack of timely follow-up of patients who experienced adverse events

  • Protocol deviations not being reported

  • Vaccines not being stored at proper temperatures

  • Mislabelled laboratory specimens, and

  • Targeting of Ventavia staff for reporting these types of problems.

Within hours Jackson received an email from the FDA thanking her for her concerns and notifying her that the FDA could not comment on any investigation that might result. A few days later Jackson received a call from an FDA inspector to discuss her report but was told that no further information could be provided. She heard nothing further in relation to her report.

In Pfizer’s briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizer’s application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. The next day the FDA issued the authorisation of the vaccine.8

In August this year, after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”

Other employees’ accounts

In recent months Jackson has reconnected with several former Ventavia employees who all left or were fired from the company. One of them was one of the officials who had taken part in the late September meeting. In a text message sent in June the former official apologised, saying that “everything that you complained about was spot on.”

Two former Ventavia employees spoke to The BMJ anonymously for fear of reprisal and loss of job prospects in the tightly knit research community. Both confirmed broad aspects of Jackson’s complaint. One said that she had worked on over four dozen clinical trials in her career, including many large trials, but had never experienced such a “helter skelter” work environment as with Ventavia on Pfizer’s trial.

“I’ve never had to do what they were asking me to do, ever,” she told The BMJ. “It just seemed like something a little different from normal—the things that were allowed and expected.”

She added that during her time at Ventavia the company expected a federal audit but that this never came.

After Jackson left the company problems persisted at Ventavia, this employee said. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.)

“I don’t think it was good clean data,” the employee said of the data Ventavia generated for the Pfizer trial. “It’s a crazy mess.”

A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research. She told The BMJ that, shortly after Ventavia fired Jackson, Pfizer was notified of problems at Ventavia with the vaccine trial and that an audit took place.

Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial; NCT04816643, NCT04754594, NCT04955626, NCT05035212). The advisory committee for the Centers for Disease Control and Prevention is set to discuss the covid-19 paediatric vaccine trial on 2 November.

Footnotes

  • Provenance and peer review: commissioned; externally peer reviewed.

  • Competing interests: PDT has been doubly vaccinated with Pfizer’s vaccine.

This article is made freely available for use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

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View Abstract

What about Novavax in NZ?

We are very supportive of vaccines in general and principle. Covid19 vaccines do not have the efficacy experienced in  previous vaccines, and have far more adverse reactions.
New Zealand has taken an unusual step (October 2021) of trying to achieve 90% uptake of the Pfizer vaccine alone. To achieve that aim it is making it mandatory to have the Pfizer vaccination if you work in some fields (health, teaching and hospitality) and after 90% is achieved, to participate in civil life (events, hospitality).
Many public and private institutions and businesses are enthusiastically complying with this project, championed by media (NZ Herald), requesting their staff are vaccinated.
Those in NZ hesitant about Pfizer have looked at other vaccine options, such as Novavax. The Government has previously said it bought enough doses for over 5 million people, and was considering using it as the ‘booster’ vaccine.
Despite that, the Government health helpline won’t talk to callers about the option of using Novavax (first hand experience, 28 Oct 2021).
Novavax, from a biological perspective, seems safer and seems to have milder adverse events than the Pfizer Covid19 vaccine, although we’d like to see some independent data on this.
It is still the spike protein, but in recombinant form (rather than mRNA), which the body then makes.
Check out:https://www.nejm.org/doi/full/10.1056/NEJMoa2107659

Waning of Covid19 vaccine effectiveness

A preprint Swedish cohort study (1.6 million people)[1] compares the risk of Covid-19 infection in vaccinated and unvaccinated people throughout the Covid-19 vaccination roll-out in the country from the 4th of January to the 4th of October 2021.

The study is based on government vaccination and health record linkage, which are generally considered reliable, due to high levels of health data capture by the government in Nordic countries.

Analysis of those who had taken the Pfizer vaccine showed that the effectiveness at preventing symptomatic infection waned from initial high levels to 47% in the period 121-180 days after the vaccine to no convincing effect beyond day 211 post-vaccination (23% reduction; 95% confidence interval, -2 to 41, P = 0·07).

This modeled decline in vaccine effectiveness is illustrated in the figure below. Such an effect was observed for all Covid-19 vaccinations used in the country, and observed for more severe health outcomes such as prevention of Covid-19 hospitalisation and death.

[1] Nordström, Peter and Ballin, Marcel and Nordström, Anna, Effectiveness of Covid-19 Vaccination Against Risk of Symptomatic Infection, Hospitalization, and Death Up to 9 Months: A Swedish Total-Population Cohort Study. Available at SSRN: https://ssrn.com/abstract=3949410  or http://dx.doi.org/10.2139/ssrn.3949410